TCTR20200224005尚未招募1 期
An Open Label, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Crossover, Fully Replicate Bioequivalence Study of GPO-Hep C (Sofosbuvir/Velpatasvir 400/100 mg/tablets) of The Government Pharmaceutical Organization, Bangkok, Th
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •i. Non-smokers, normal, healthy, adult, human subjects between 18 and 45 years of age (both
- •inclusive).
- •ii. Having a Body Mass Index (BMI) between 18.0 and 30.0 (both inclusive), calculated as weight in
- •kg/height in m2.
- •iii. Not having significant diseases or clinically significant abnormal findings during screening, medical
- •history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings
- •(postero-anterior view).
- •iv. Able to understand and comply with the study procedures, in the opinion of the investigator.
- •v. Able to give voluntary written informed consent for participation in the trial.
- •vi. In case of female subjects:
- •â€¢ Surgically sterilized at least 06 months prior to study participation;
- •â€¢ If of child bearing potential is willing to use a suitable and effective double barrier contraceptive
- •method or intra uterine device during the study.
- •â€¢ Serum pregnancy test must be negative.
排除标准
- •Exclusion Criteria
- •i. Known hypersensitivity to Sofosbuvir and Velpatasvir or any excipients or any related drug or any
- •ii. History or presence of any disease or condition which might compromise the haemopoietic, renal,hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,
- •gastrointestinal or any other body system.
- •iii. Ingestion or Use of any medication [prescribed medication & over the counter (OTC) medication
- •including herbal remedies] at any time in 14 days prior to dosing of period-I. In any such case
- •subject selection will be at the discretion of the Principal Investigator.
- •iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs
- •induced urticaria.
- •v. Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in
- •vi. Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks),
- •tobacco, tobacco containing products (gutkha, pan/pan masala) 24 hours prior to IMP administration
- •of period-I.
- •vii. Smokers or who have smoked within last 06 months prior to start of the study
- •viii. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than
- •14 standard drinks per week for men and more than 7 standard drinks per week for women (A
- •standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such
- •as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to
- •dosing in Period-I.
- •ix. The presence of clinically significant abnormal laboratory values during screening.
- •x. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
- •xi. History or presence of seizure or psychiatric disorder
- •xii. A history of difficulty with donating blood.
- •xiii. Difficulty in swallowing solids dosage forms like tablets or capsules.
- •xiv. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study
- •medication.
- •xv. Receipt of an investigational medicinal product or participation in a drug research study within a
- •period of 90 days prior to the first dose of study medication**.
- •** If investigational medicinal product is received within 90 days where there is no blood loss except
- •safety lab testing, subject can be included considering 10 half-lives duration of investigational
- •medicinal product received.
- •xvi. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •xvii. A positive test result for HIV antibody (1 & 2).
- •xviii. An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four
- •weeks prior to receiving the study drug in period I. In any such case subject selection will be at the
- •discretion of the Principal Investigator.xix. Nursing mothers (for female subjects).
研究者
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